Sleep-disordered Breathing and Perioperative Atrial Fibrillation in Cardiac Surgery

• Conditions: Coronary Artery Disease; Elective Coronary Artery Bypass Grafting (CABG) Surgery; Sleep-disordered Breathing (SDB); Atrial Fibrillation
• Interventions: Other: Stratification, no intervention

• Registration Number: NCT02877745
• Lead Sponsor: Michael Arzt

Brief Summary

In patients undergoing elective coronary artery bypass grafting (CABG) surgery, coronary artery disease, sleep-disordered breathing (SDB), atrial fibrillation (AF) perioperative atrial fibrillation and complications will be assessed. The primary objective is to determine, whether SDB patients have a higher rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) within 30 days after surgery compared to those without SDB.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-31
• Study First Submitted QC: 2016-08-19
• Study First Posted: 2016-08-24
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-16
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Patients undergoing elective CABG surgery at the Department of Cardiac and Thoracic Surgery, University Hospital Regensburg.
• Written informed consent

Exclusion Criteria

• Preoperative use of inotropes or intra aortic balloon pump
• Severe obstructive pulmonary disease
• Patients on oxygen therapy, nocturnal positive airway pressure support or mechanical ventilation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SDB	Stratification, no intervention	apnea-hyponea index \>=15/hour
no SDB	Stratification, no intervention	apnea-hyponea index \<15/hour

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac and Cerebrovascular Events (MACCE)	30 days	periprocedural and late myocardial infarction (MI), non-fatal stroke and transitory ischemic attack (TIA) as well as all-cause mortality

Secondary Outcome Measures

Name	Time	Method
postoperative atrial fibrillation (POAF)	30 days after CABG surgery	assessed by ECG
Stroke	within 1 year after CABG surgery	assessed by questionnaire
MACCE	within 1 and 2 years after CABG surgery	assessed by questionnaire
Major pulmonary complications	within 30 days as well as 1 and 2 years	assessed by questionnaire

Trial Locations

Locations (1)

Department of Internal Medicine II, University Hospital; 🇩🇪 Regensburg, Germany